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NCT Number: NCT07368192

Community-Based Exercise Oncology: Real-World Evidence of High Adherence, Improved Quality of Life and Cost-Effectiveness Across the Cancer Continuum

This prospective observational cohort study evaluates a community-based supervised exercise oncology program delivered in real-world settings in Madrid, Spain. The program is designed for adults with a cancer diagnosis across the cancer continuum, including survivors, patients undergoing active treatment, individuals receiving hormonotherapy, and patients with metastatic disease.

Participants take part in a structured multimodal exercise program combining aerobic, resistance, and functional training, delivered in supervised group-based sessions either in person or through synchronous online formats. The primary aims of the study are to assess program adherence, health-related quality of life, fatigue, and cost-effectiveness, expressed as quality-adjusted life years (QALYs). Secondary outcomes include cardiorespiratory fitness, muscular strength, functional capacity, physical activity levels, body composition, and psychological well-being.

Assessments are conducted at baseline and every four months over a 12-month follow-up period. This study provides real-world evidence on the feasibility, clinical impact, and economic value of community-based exercise oncology programs across different stages of the cancer trajectory.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Cancer Neoplams Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ejercicio y Cáncer Center

Madrid, 28007, Spain

About this study

This study is a prospective observational cohort analysis of adults with a confirmed cancer diagnosis participating in a community-based supervised exercise oncology program in Madrid, Spain. Participants are referred by oncology specialists or self-referred with medical clearance to engage in moderate-intensity physical exercise.

The intervention consists of supervised multimodal exercise sessions lasting approximately 75 minutes, including warm-up, combined aerobic and resistance training, and cool-down periods. Aerobic training is prescribed using heart rate reserve and perceived exertion scales, while resistance training includes free-weight and functional exercises targeting major muscle groups. Sessions are delivered in small groups either face-to-face or via synchronous online platforms, with individualized progression and safety monitoring.

Participants undergo standardized assessments at baseline and at 4, 8, and 12 months. Primary outcomes include adherence to supervised exercise sessions, health-related quality of life, fatigue, and cost-effectiveness measured through quality-adjusted life years derived from EQ-5D instruments. Secondary outcomes include estimated cardiorespiratory fitness, muscular strength, functional capacity tests, physical activity behavior, body composition, and psychological outcomes.

The study aims to generate real-world evidence on the feasibility, effectiveness, and economic impact of integrating structured exercise programs into community-based cancer care across different clinical stages of disease.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years.
  • Confirmed diagnosis of cancer, at any stage of disease.
  • Medical clearance to perform moderate-intensity physical exercise.
  • Able to ambulate independently without assistive devices.
  • Willingness to attend supervised exercise sessions for a follow-up period of at least 12 months.

Exclusion criteria

  • Absolute medical contraindications to exercise (e.g., unstable angina, uncontrolled arrhythmias, severe anemia, acute infection, or thrombosis).
  • Unstable metastatic bone disease without radiologic and/or oncologic clearance.
  • Cognitive or functional impairment preventing safe participation in the exercise program.
  • Concurrent participation in another structured exercise intervention or clinical trial.

Treatment and study plan

Primary outcomes

  1. Adherence

    Time frame: Baseline, 4 months, 8 months, and 12 months.

    Percentage of supervised exercise sessions completed out of scheduled sessions.

  2. Health-related quality of life (FACT-G)

    Time frame: Baseline, 4 months, 8 months, and 12 months.

    Health-related quality of life (units on a scale) assessed using the Functional Assessment of Cancer Therapy - General (FACT-G)

  3. Fatigue (FACT-F)

    Time frame: Baseline, 4 months, 8 months, and 12 months.

    Fatigue (units on a scale) assessed using the Functional Assessment of Chronic Illness Therapy - Fatigue (FACT-F).

  4. Quality-adjusted life years (QALYs)

    Time frame: Baseline, 4 months, 8 months, and 12 months.

    Quality-adjusted life years calculated by integrating EQ-5D utility scores collected at multiple time points over the 12-month follow-up period. Repeated EQ-5D measurements are aggregated to derive a single QALY value per participant.

  5. Barriers to participation

    Time frame: Baseline, 4 months, 8 months, and 12 months.

    Using a structured questionnaire based on previously published frameworks on determinants of adherence in cancer survivors.

Secondary outcomes

  1. Estimated VO₂max

    Time frame: Baseline, 4 months, 8 months, and 12 months.

    Estimated maximal oxygen uptake (VO₂max) assessed using the Bruce treadmill protocol and Mackenzie equation.

  2. Muscular strength

    Time frame: Baseline, 4 months, 8 months, and 12 months.

    Upper- and lower-limb muscular strength (kg) estimated using submaximal tests to estimate one-repetition maximum (1RM).

  3. Functional capacity

    Time frame: Baseline, 4 months, 8 months, and 12 months.

    Functional capacity assessed using the 6-Minute Walk Test (6MWT) in meters.

  4. Functional capacity

    Time frame: Baseline, 4 months, 8 months, and 12 months.

    Functional capacity assessed using the 30-second Sit-to-Stand test (repetitions)

  5. Body weight (kg)

    Time frame: Baseline, 4 months, 8 months, and 12 months.

    Body weight assessed by bioelectrical impedance analysis using the Tanita MC-601F.

  6. Body Fat Percentage (%)

    Time frame: Baseline, 4 months, 8 months, and 12 months.

    Body Fat Percentage (%) assessed by bioelectrical impedance analysis (Tanita MC-601F).

  7. Fat Mass (kg)

    Time frame: Baseline, 4 months, 8 months, and 12 months.

    Fat Mass (kg) assessed by bioelectrical impedance analysis (Tanita MC-601F).

  8. Lean Mass Percentage (%)

    Time frame: Baseline, 4 months, 8 months, and 12 months.

    Lean Mass Percentage (%) assessed by bioelectrical impedance analysis (Tanita MC-601F).

  9. Lean Mass (kg)

    Time frame: Baseline, 4 months, 8 months, and 12 months.

    Lean Mass (kg) assessed by bioelectrical impedance analysis (Tanita MC-601F).

  10. Physical activity

    Time frame: Baseline, 4 months, 8 months, and 12 months.

    Physical activity levels assessed using the International Physical Activity Questionnaire (IPAQ). The IPAQ estimates total physical activity expressed as metabolic equivalent minutes per week (MET-min/week), calculated from self-reported frequency, duration, and intensity of physical activity. Scores range from 0 MET-min/week to no upper limit, with higher values indicating higher levels of physical activity.

  11. Anxiety (HADS-A)

    Time frame: Baseline, 4 months, 8 months, and 12 months.

    Symptoms of anxiety (units on a scale) assessed using the Hospital Anxiety Scale (HADS-A) The HADS-A consists of 7 items scored from 0 to 3, yielding a total score ranging from 0 to 21, with higher scores indicating greater severity of anxiety symptoms.

  12. Depression (HADS-D)

    Time frame: Baseline, 4 months, 8 months, and 12 months.

    Depressive symptoms assessed using the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D). The HADS-D consists of 7 items scored from 0 to 3, yielding a total score ranging from 0 to 21, with higher scores indicating greater severity of depressive symptoms.

Sponsors and collaborators

Lead sponsor

University of Castilla-La Mancha

Other

Collaborators

  • Ejercicio y Cáncer (Community Exercise Program)
  • Universidad Pontificia Comillas

Registry information

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Jan 26, 2026
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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